The lawsuit was filed by Jeremy K., a man who was implanted with the Cook Celect® Vena Cava Filter on May 29, 2012 at St. Francis Medical Center in Peoria, Illinois.
Celect is a cage-like device that is implanted in a major vein called the inferior vena cava (IVC) to catch blood clots floating in the bloodstream (called “embolisms”) before they get stuck in the lungs.
Cook Medical designed Celect as a retrievable version of the Günther Tulip, with 12 needle-like wire legs arranged in a cone-shape around a central hook, so a surgeon can lasso the hook and remove the filter.
Celect was introduced in 2007, but it had many of the same problems as the Günther Tulip — and perhaps even more.
One of the most common problems occurs when Celect’s needle-like legs dig into the vein and puncture through. In a study from 2012, 86% of Celect patients suffered a perforation within 5 months, on average.
Complication rates increase over time, so the FDA recommends removing temporary filters as soon as protection from pulmonary embolism is no longer needed.
Even so, removal rates are very low — only about 30% are removed, on average. Less than 10% are removed from trauma patients.
Trauma patients present an interesting case study in the controversy over IVC filters. Trauma patients have a high risk of developing deadly blood clots in a hospital bed, but most patients can’t take blood-thinning medications due to their injuries.
So when temporary filters were approved, some hospitals began routinely implanting them in trauma patients — even patients who did not actually have blood clots. The use of IVC filters skyrocketed from 49,000 per year in 1999 to around 259,000 in 2012.
The problem is that IVC filters do not actually reduce the risk of death for trauma patients, according to recent studies.
Ironically, one of the most common long-term complications is developing blood clots — the very same injury the filter was supposed to prevent. In 2015, a study found “no survival benefit” to implanting an IVC filter in a trauma patient, but an 84% increased risk of Deep Vein Thrombosis (DVT).
It is important to look at the big picture when considering the overall safety of a medical device. Cook Medical is accused of failing to warn about life-threatening side effects, and inadequately testing temporary IVC filters for long-term safety.
The lawsuit was filed on January 12, 2017 in the U.S. District Court for the Southern District of Indiana (Indianapolis Division) — Case No. 1:16-cv-00131.
It will be centralized with over 1,225 other IVC filter lawsuits now pending in Multi-District Litigation (MDL No. 2570) — In Re: Cook Medical, Inc., IVC Filters Marketing, Sales Practices, and Products Liability Litigation.
The plaintiff is represented by Ben C. Martin and Thomas Wm. Arbon of The Law Offices of Ben C. Martin.
Ben C. Martin is a trial attorney based in Dallas, Texas who serves as the plaintiffs’ co-lead counsel in the Cook IVC Filter MDL.